A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/21/2019
Start Date:January 4, 2017
End Date:July 25, 2022
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)

M2951 is an investigational drug under evaluation for treatment of autoimmune and
inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of
M2951 in Subjects with Systemic Lupus Erythematosus (SLE)


Inclusion Criteria:

- Eligible male and female subjects, aged 18 to 75 years

- Must have diagnosis of SLE with either the Systemic Lupus International Collaborating
Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of
Rheumatology (ACR) classification criteria for SLE, of at least six months duration
prior to Screening

- SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI
greater than or equal to (>=) 4) at Screening Visit

- And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or
anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith
(anti-Sm) antibody at the time of Screening

- Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

- Subjects are not eligible for this study if they have active, clinically significant
interstitial lung disease or pulmonary arterial hypertension

- Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)

- Acutely worsened renal function

- Central nervous system SLE

- Or within two weeks prior to Screening or during Screening: use of oral
corticosteroids greater than (>) 30 mg daily prednisone equivalent

- Use of injectable corticosteroids, or change in dose of corticosteroids.

- Other protocol defined exclusion criteria could apply.
We found this trial at
49
sites
Glendale, Arizona 85304
Principal Investigator: Swati Bharadwaj
336
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Glendale, AZ
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Vasileios Kyttaris
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2578
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
2189
mi
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Chapel Hill, NC
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
1609
mi
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Jackson, MS
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
11
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Los Angeles, CA
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Anaheim, California 92805
Principal Investigator: Rafaelito Victoria
18
mi
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Anaheim, CA
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Anniston, Alabama 36207
Principal Investigator: Vishala Chindalore
1842
mi
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Anniston, AL
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Aurora, Colorado 80045
Principal Investigator: Susan Boackle
825
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Aurora, CO
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Bay City, Michigan 48706
Principal Investigator: Jeffrey Potts
1933
mi
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Bay City, MI
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Bronx, New York 10467
2439
mi
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Bronx, NY
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Chicago, Illinois 60637
1729
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Chicago, IL
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Clearwater, Florida 33765
Principal Investigator: Robert Levin
2116
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Clearwater, FL
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Covina, California 91723
Principal Investigator: Samy Metyas
7
mi
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Covina, CA
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Dallas, Texas 75231
Principal Investigator: Roy Fleischmann
1225
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Dallas, TX
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Debary, Florida
Principal Investigator: Sanjiv Kapil
2180
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Debary, FL
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Detroit, Michigan 48202
Principal Investigator: Kathleen Maksimowicz-McKinnon
1965
mi
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Detroit, MI
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Flint, Michigan
Principal Investigator: Ali Karrar
1939
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Flint, MI
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Fort Lauderdale, Florida 33334
Principal Investigator: Yvonne Sherrer
2315
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Fort Lauderdale, FL
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Glendale, California 91204
Principal Investigator: Dan La
14
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Glendale, CA
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Greensboro, North Carolina 27408
Principal Investigator: Tauseef Syed
2151
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Greensboro, NC
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7021 Augusta Road
Greenville, South Carolina 29604
Principal Investigator: Jeffrey Lawson
2020
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Greenville, SC
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Houston, Texas 77004
Principal Investigator: Jacqueline Vo
1358
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Houston, TX
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Houston, Texas
Principal Investigator: Philip Waller
1357
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Houston, TX
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La Palma, California 90623
Principal Investigator: Gerald Ho
15
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La Palma, CA
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Lakewood, California 90712
Principal Investigator: Wagdy Kades
16
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Lakewood, CA
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Los Angeles, California 90048
Principal Investigator: Daniel Wallace
20
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Los Angeles, CA
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Mar del Plata, Buenos Aires B7600
Principal Investigator: Juan Pablo Gulin
6309
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Mar del Plata,
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
1908
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Marietta, GA
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Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
355
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Mesa, AZ
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Miami, Florida
Principal Investigator: Juan Prieto
2322
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Miami, FL
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New Haven, Connecticut 06520
Principal Investigator: Fotios Koumpouras
2486
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New Haven, CT
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
2434
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New York, NY
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Phoenix, Arizona 85037
Principal Investigator: John Tesser
333
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Susan Manzi
2118
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Pittsburgh, PA
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Plantation, Florida
Principal Investigator: Guillermo Valenzuela
2310
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Plantation, FL
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Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
2218
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Raleigh, NC
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Saint Louis, Missouri 63110
1568
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Saint Louis, MO
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4650 Palm Avenue
San Diego, California 92154
Principal Investigator: Steve Lee
117
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San Diego, CA
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San Leandro, California 94578
Principal Investigator: Suneet Grewal
340
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San Leandro, CA
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Seattle, Washington
Principal Investigator: Sergey Moiseev
961
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Seattle, WA
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Shreveport, Louisiana
Principal Investigator: Sarwat Umer
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Shreveport, LA
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Syracuse, New York 13210
Principal Investigator: Andras Perl
2320
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Syracuse, NY
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Tampa, Florida 33613
Principal Investigator: Harris McIlwain
2132
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Tampa, FL
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Tampa, Florida
2136
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Tampa, FL
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The Woodlands, Texas
Principal Investigator: Amber Khan
1342
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The Woodlands, TX
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Tomball, Texas 77375
Principal Investigator: Shaikh Ali
1336
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Tomball, TX
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Upland, California 91786
Principal Investigator: Antony Hou
20
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Upland, CA
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451 North Texas Avenue
Webster, Texas 77598
Principal Investigator: Abdelnaser Elkhalili
1376
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Webster, TX
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23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz
36
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West Hills, CA
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